Aurobinda Pharma
Senior General Manager - Corporate QA
(Sterile Assurance)
1. Harmonization of
procedures and practices:
a. Draft / review / update Policies, Procedures related to
Microbiology and
Sterile Assurance.
b. Harmonize the Procedures related to Microbiology and
Sterile Assurance
across all units
2. Improving breadth and depth of Knowledge:
a. Identify and lead a network of Microbiology / Sterile
Assurance Subject
Matter Experts.
b. Act as a CQA Trainer for Microbiology and Sterile
Assurance related Training
programs.
3. Investigations and CAPA:
a. Act as CAPA coordinator for the CAPA related to
Microbiology and Sterile
Assurance.
b. Part of Investigations Team for Microbiology and Sterile
related
Investigations.
c. Act as Cross Functional Reviewer (CQA) for
Microbiology and Sterile
Assurance related changes, Non
conformances, OOS etc, wherever applicable.
4. Act as Internal Auditor for Microbiology and Sterile
Assurance area,
wherever required.
5. Proactively assess risk, plan and execute audit
deliverables. Work with
sites to ensure their sterility
assurance systems are properly prepared for
external and
internal compliance inspections.
6. Escalate Microbiology and Sterile Assurance related
issues to Senior Management.
Years
of Experience 22-25 years
Education
Qualification for the position M.Pharm, M.Sc
(Microbiology)
Deputy Manager /
Manager - SCM (Supply Planning / Production Planning)
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